FDA Inspections in 2021 Amidst COVID-19

FDA Inspections in 2021 Amidst COVID-19

Have routine FDA inspections resumed in any capacity? If not, what can industry members expect in 2021 amidst COVID-19? At the onset of the COVID-19 pandemic in 2020, FDA announced a temporary halt to on-site facility inspections. With few exceptions, the agency made...
Supreme Court Settles Fate of DMAA

Supreme Court Settles Fate of DMAA

The U.S. Supreme Court has settled its fate and denied a petition for a writ of certiorari filed by a supplement manufacturer Hi-Tech Pharmaceuticals and its owner, Jared Wheat. The nation’s highest court has rejected a request to review a case involving the legality...
Musclegen Guilty for SARMs Distribution

Musclegen Guilty for SARMs Distribution

The owner of a North Carolina-based sports supplement company Musclegen pleaded guilty to selling unapproved drugs and agreed to forfeit the money earned from the illegal business. Selective androgen receptor modulators (SARMs) are drugs under development for...
COVID-19 Drives Demand for Immune-Boosters

COVID-19 Drives Demand for Immune-Boosters

As COVID-19 drives continued demand for immune booster dietary supplements, new disruptions in the supply chain emphasize the need for quality assurance. The COVID-19 pandemic has been an accelerator for the dietary supplement industry, with sales at record-breaking...
Tips on Ensuring Your Product Is FDA Compliant

Tips on Ensuring Your Product Is FDA Compliant

When selling food, cosmetics, drugs, and medical devices, you think beyond the figures of your sales and the performance of your product in the market. You must also keep up with the various rules and regulations established by the Food and Drug Administration (FDA)...